Catalog Number

-

Brand Name

Valleylab

Version/Model Number

E2100

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K942183,K942183

Product Code

GEI

Product Code Name

ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Public Device Record Key

b8de62c5-0014-442c-9ce3-05003691c894

Public Version Date

May 23, 2022

Public Version Number

6

DI Record Publish Date

September 24, 2016

Package DI Number

10884524001593

Quantity per Package

10

Contains DI Package

20884524001590

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE